A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in the Treatment of Symptomatic Internal Hemorrhoids.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Reduction in Swelling
研究概览
简要总结
A randomized, double-blind, placebo-controlled, multicenter, parallel group study of the safety and efficacy of Hydrocortisone Acetate Suppositories, 25 mg compared to placebo suppositories in the treatment of symptomatic internal hemorrhoids.
详细描述
STUDY DESIGN:
25 mg hydrocortisone suppositories administered twice daily compared to a vehicle placebo in approximately 100 subjects with symptomatic internal hemorrhoids. Subjects will be randomized in a 1:1 ratio (Test product: placebo).
The study will consist of 2 periods:
- Treatment Period (2 weeks/ Days 1-14)
- Follow-up Period (2 weeks/ Days 15-28)
The visits are as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •internal hemorrhoids.
- •hemorrhoidal bleeding.
- •male or female aged 18 years and older.
- •willing to forego the use of non-prescription (OTC) and prescription medication or procedures for the treatment of hemorrhoidal disease and/or pain for the duration of the study.
- •agree to not change their diet during the study.
排除标准
- •external hemorrhoids.
- •using other OTC or prescription medications for treatment of hemorrhoidal disease and/or pain.
- •pregnant or nursing female.
- •received systemic glucocorticoids within the last 2 months prior to starting study.
- •participated in an investigational drug study within 30 days prior to baseline.
研究组 & 干预措施
Hydrocortisone Acetate Suppository, 25 mg
One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
干预措施: Hydrocortisone Acetate Suppository, 25 mg (Nivagen) (Drug)
Placebo (Vehicle) Suppository
One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
干预措施: Placebo (Vehicle) Suppository (Nivagen) (Drug)
结局指标
主要结局
Reduction in Swelling
时间窗: Day 15
Reduction in the swelling of internal hemorrhoid was measured by anoscopy. Visual assessment of hemorrhoids was performed at end of treatment. Video of the procedure will be recorded for blinded central reading and assessment. Swelling was graded on a scale from "0 - None" to "4 - Very Severe". Numeric grades and their changes from baseline are summarized descriptively by visit and treatment group. Changes from baseline will be compared between the treatment groups. Mean difference between the groups and its 95% confidence interval will be displayed at Visit 4, along with the p-value from the two-sample t-test.
Reduction in Itching Severity
时间窗: Day 15
Patient-reported outcome (PRO) was collated and analyzed by deploying the Internal Hemorrhoid Sign and Symptom Assessment (IHSSA) questionnaire. The patients updated the questionnaire on a daily basis between visits 1-5. Responses to each item were averaged across each period. The mean score from the Screening period was considered the baseline score. Mean scores and their changes from baseline were summarized. Itching was scored from on 0-4 scale (0 =No itching, 1 = A little itching, 2 =Moderate itching, 3 = A lot of itching, 4 = Worst itching that you could imagine
次要结局
未报告次要终点